(62 days)
Not Found
No
The document describes a laser fiber for soft tissue procedures and does not mention any AI or ML components or functionalities.
Yes
The device is described for procedures such as vaporization, cutting, ablation, and coagulation of soft tissue in various medical specialties, which are all therapeutic actions.
No
The intended use describes the device for surgical procedures like vaporization, cutting, ablation, and coagulation of soft tissue, not for diagnosing conditions.
No
The device description, while not explicitly provided, refers to a "fiber" and "handpiece," which are physical components, indicating it is not a software-only device. The intended use also describes physical actions like vaporization, cutting, ablation, and coagulation of soft tissue, which are performed by hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures (vaporization, cutting, ablation, coagulation of soft tissue) directly on the patient's body, either through endoscopic equipment or open surgery.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue samples) taken from the human body to provide information about a person's health. This device does not perform such analysis on specimens.
The description focuses on the physical interaction of the laser fiber with tissue within the body, which is characteristic of a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Dornier Lasertrode fiber is intended to be used for vaporization, cutting, ablation and coaqulation of soft tissue in conjunction with or without endoscopic equipment including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes, or for open surgery for contact or non-contact surgery with or without handpiece for use in coagulation, incision/excision, ablation and vaporization of soft tissue.
The Dornier Lasetrode is indicated for use in medicine and surgery in the following specialties: Urology, Plastic Surgery, Radiology, Dermatology, Pulmonology, Gastroenterology, Gynecology, ENT and General Surgery.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
9 1999 JUN
DornierMedTech
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Dornier Surgical Products, Inc.'s Lasertrode Fiber
In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
The safety and effectiveness of the Dornier Lasertrode is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which includes the following:
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
| Dornier Surgical Products, Inc. | Phone: | 770-426-1315 |
|---|---|---|
| 10027 South 51st Street | Facsimile: | 770-514-6288 |
| Phoenix, AZ 85044 | ||
| Contact Person: Carol Wernecke | Date Prepared: March 31, 1999 |
Name of Device and Name/Address of Sponsor
Dornier Lasertrode Fiber Dornier Surgical Products, Inc. 10027 South 51st Street Phoenix. AZ 85044
Classification Name
Laser Surgical Instrument Accessories.
Predicate Devices
Dornier Light Guide with Bare Fiber Tip (K982629)
Intended Use
The Dornier Lasertrode fiber is intended to be used for vaporization, cutting, ablation and coaqulation of soft tissue in conjunction with or without endoscopic equipment including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes, or for open surgery for contact or non-contact surgery with or without handpiece for use in coagulation, incision/excision, ablation and vaporization of soft tissue.
1
The Dornier Lasetrode is indicated for use in medicine and surgery in the following specialties: Urology, Plastic Surgery, Radiology, Dermatology, Pulmonology, Gastroenterology, Gynecology, ENT and General Surgery.
Technological Characteristics and Substantial Equivalence
From a clinical perspective and comparing design specifications, the Dornier Lasertrode Fiber and the predicate device are substantially equivalent and have the same intended use.
Dornier Surgical Products, Inc. believes the minor differences of the Dornier Lasertrode fiber and its predicate laser accessories should not raise any concerns regarding the overall safety or effectiveness.
- Advisory: This information was prepared for the sole purpose of compliance with the Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community and support. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
9 1999 JUN
Ms. Carol Wernecke Director, Regulatory and Clinical Affairs Dornier Medical Systems, Inc. 1155 Roberts Boulevard Kennesaw, Georgia 30144
Re: K991183 Trade Name: Dornier Lasertrode Fiber Regulatory Class: II Product Code: GEX Dated: April 5, 1999 Received: April 8, 1999
Dear Ms. Wernecke:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
3
Page 2 - Ms. Carol Wernecke
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Dornier Surgical Products, Inc.'s Lasertrode
INDICATIONS FOR USE
The Domier Lasertrode fiber is intended to be used for vaporization, cutting, ablation and coagulation of soft tissue in conjunction with or without endoscopic equipment including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes, or for open surgery for contact or non-contact surgery with or without handpiece for use in coagulation, incision/excision, ablation and vaporization of soft tissue.
The Dornier Lasetrode is indicated for use in medicine and surgery in the following specialties: Urology, Plastic Surgery, Radiology, Dermatology, Pulmonology, Gastroenterology, Gynecology, ENT and General Surgery.
Prescription Use
(Per 21 CFR 801.109)
Acotefa